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Clinical Trials/NL-OMON50533
NL-OMON50533
Completed
Phase 2

A randomised, double-blind, controlled trial to evaluate the effects of a new human milk fortifier on growth and tolerance in preterm infants. - Renoir

utricia Research0 sites75 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
utricia Research
Enrollment
75
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
utricia Research

Eligibility Criteria

Inclusion Criteria

  • •1\. Preterm infants fed own mother\*s milk (or donor human milk) in need of a HMF
  • •(as decided by the investigator)
  • •2\. Gestational age \<32 weeks and birth weight \<1500 g
  • •3\. Receiving enteral feeding
  • •4\. Expected to be in need of a HMF for minimally 21 days
  • •5\. Written informed consent from custodial parent(s)

Exclusion Criteria

  • •1\. Any relevant proven or suspected chromosomal anomaly, metabolic disorder,
  • •genetic syndrome or congenital central nervous system malformation
  • •2\. Presence or history of any gastrointestinal malformation/compromise,
  • •including Necrotising enterocolitis (NEC) (defined as Bell\*s stage two or

Outcomes

Primary Outcomes

Not specified

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